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Safety and effectiveness responses to etanercept for rheumatoid arthritis in Japan: a sub-analysis of a post-marketing surveillance study focusing on the duration of rheumatoid arthritis

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Title: Safety and effectiveness responses to etanercept for rheumatoid arthritis in Japan: a sub-analysis of a post-marketing surveillance study focusing on the duration of rheumatoid arthritis
Authors: Koike, Takao Browse this author →KAKEN DB
Harigai, Masayoshi Browse this author
Inokuma, Shigeko Browse this author
Ishiguro, Naoki Browse this author
Ryu, Junnosuke Browse this author
Takeuchi, Tsutomu Browse this author
Tanaka, Yoshiya Browse this author
Yamanaka, Hisashi Browse this author
Fujii, Koichi Browse this author
Yoshinaga, Takunari Browse this author
Freundlich, Bruce Browse this author
Suzukawa, Michio Browse this author
Keywords: Antirheumatic agents/adverse effects
Antirheumatic agents/therapeutic use
Arthritis, rheumatoid/drug therapy
Product surveillance, Postmarketing/statistics & numerical data
Receptors, tumor necrosis factor/therapeutic use
Japan
Issue Date: Jun-2012
Publisher: Springer Berlin / Heidelberg
Journal Title: Rheumatology International
Volume: 32
Issue: 6
Start Page: 1511
End Page: 1519
Publisher DOI: 10.1007/s00296-010-1784-8
Abstract: The aim is to investigate the relationship of duration of rheumatoid arthritis (RA) with safety and effectiveness of etanercept (ETN) in Japan. Post-marketing surveillance data for 7,099 patients treated with ETN were analyzed. Baseline characteristics, treatment effectiveness, incidence of adverse events (AEs), and serious AEs (SAEs) in relation to duration of RA were studied. At baseline, patients with RA for longer duration were older, weighed less, had more comorbidities, allergies, and corticosteroid use, but smoked less and had less morning stiffness. By 2-5 years with RA, more than half of the patients had advanced to Steinbrocker radiographic stage III or IV. Methotrexate (MTX) was the most commonly used pre-treatment disease-modifying antirheumatic drug; however, concomitant MTX use and its dose were lower among patients with longer duration of RA. Remission rates (26.6%) were greatest among patients having RA for <2 years. Less AEs and SAEs were observed among patients with shorter duration of RA. These results suggest that RA treatment in Japan in the era pre-biologics may not have been adequate to control disease activity and prevent joint destruction. Patients with shorter duration of RA may have better physical status which allows the opportunity to treat more intensively putting a higher percentage of patients in remission and possibly decreasing exposure to SAEs.
Type: article
URI: http://hdl.handle.net/2115/49677
Appears in Collections:医学院・医学研究院 (Graduate School of Medicine / Faculty of Medicine) > 雑誌発表論文等 (Peer-reviewed Journal Articles, etc)

Submitter: 小池 隆夫

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